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Revised DRAFT (0 4

- 1 as of 10-18 -2010 ) 3
BILLING CODE 6560–50–P 4

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ENVIRONMENTAL PRO TECTION AGENCY 6

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40 CFR Part 152.5 8

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# i [EPA–HQ–OPP–2010- XX 0427 ; FRL– XXXX

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# i RIN 2070

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Declaration of Prion as a Pest under FI FRA and Amendment of EPA’s Regulatory 15
Definition of Pests to Include Prion 16

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AGENCY: Environmental Protection Agency (EPA). 18

ACTION: Proposed rule. 19

SUMMARY: EPA proposes to declare a prion (i.e., pr oteinaceous in fectious particle) a 20 “pest” under the Federal Ins ecticide, Fungicide, and Roden ticide Act (FIFRA), and to 21 amend its regulations to expres sly include prion with in the regulatory definition of pest. 22 EPA currently considers a pr ion to be a pest under FIFR A, so a product intended to 23 reduce the infectivity of any prion on inanimate surfaces (i.e., a “prion -related product”) 24 is considered to be a pesticide and regulated as such. Any company seeking to distribute 25 or sell a pesticide product regu lated under FIFRA must obtain EPA approval a Section 3 26 registration, Section 24(c) registration or a Section 18 emergency exemption before it can 27
be distributed or sold in the United States. This proposed rule would codify the Agency’s 28 current interpretation of FIFRA, and provi des interested parties the opportunity to 29 comment about how it is adding prion to the list of pests in 40 CFR Part 152.5. This 30 amendment, together with the formal declarati on that a prion is a pest, will eliminate any 31 confusion about the status of prion -related products under FIFRA. Codifying the 32 Agency’s current interpretation of FIFRA will not change the manner in which EPA 33 currently regulates prion -related products under FIFRA Sections 3, 24(c) and 18. 34 Regulating prion -related products under FIFRA is appropriate for protecting human 35 health and the environment against unreasona ble adverse effects and ensuring that such 36 products are effective. 37

DATES: Comments must be recei ved on or before [ insert date 60 days after date of 38 publication in the Federal Register ]. 39*** EO 12866 Review Draft – Delib erative – Do Not Cite, Quote or Release During the Review *** Page 2 of 17

ADDRESSES: Submit your comments, identified by docket identification (ID) number 1 EPA–HQ–OPP–2010– XX 0427 , by one of the following methods: 2

• Federal eRulemaking Portal : http://www.regulations.gov . Follow the on-line 3 instructions for submitting comments. 4

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• Mail : Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), 6 Environmental Protection Agency, 1200 Pe nnsylvania Ave., NW., Washington, DC 7
20460–0001. 8

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• Delivery : OPP Regulatory Public Docket ( 7502P), Environmental Protection 10 Agency, Rm. S–4400, One Potomac Yard (S outh Bldg.), 2777 S. Crystal Dr., Arlington, 11 VA. Deliveries are only accepted during the Do cket Facility’s normal hours of operation 12 (8:30 a.m. to 4 p.m., Monday through Fr iday, excluding legal holidays). Special 13 arrangements should be made for deliveries of boxed information. The Docket Facility 14 telephone number is (703) 305–5805. 15

Instructions : Direct your comments to doc ket ID number EPA–HQ–OPP–2010- 16

XX 0427 . EPA's policy is that all comments r eceived will be included in the docket 17 without change and may be made available on-line at http://www.regulations.gov

, 18 including any personal information provide d, unless the comment includes information 19
claimed to be Confidential Business Info rmation (CBI) or other information whose 20 disclosure is restricted by st atute. Do not submit informati on that you consider to be CBI 21 or otherwise protected through regulations.gov or e-mail. The regulations.gov website is 22 an “anonymous access” system, which means EP A will not know your identity or contact 23 information unless you provide it in the body of your comment. If you send an e-mail 24 comment directly to EPA without going through regulations.gov, your e-mail address 25 will be automatically captured and included as part of the comment that is placed in the 26
docket and made available on the Internet. If you submit an electronic comment, EPA 27 recommends that you include your name and other contact information in the body of 28 your comment and with any disk or CD-ROM you submit. If EPA cannot read your 29
comment due to technical difficulties and cannot contact you for clarification, EPA may 30 not be able to consider your comment. El ectronic files should a void the use of special 31 characters, any form of encryption, and be free of any defects or viruses. 32

Docket : All documents in the docket are list ed in the docket index available at 33 http://www.regulations.gov . Although listed in the index, some information is not 34 publicly available, e.g., CBI or other information whose disclosure is re stricted by statute. 35 Certain other material, such as copyrighted ma terial, is not placed on the Internet and will 36 be publicly available only in hard copy form. Publicly av ailable docket materials are 37
available either in the electronic docket at http://www.regulations.gov , or, if only 38 available in hard copy, at the OPP Regul atory Public Docket in Rm. S–4400, One 39 Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. Th e hours of operation 40 of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday through Friday, excluding 41 legal holidays. The Docket Facili ty telephone number is (703) 305–5805. 42*** EO 12866 Review Draft – Delib erative – Do Not Cite, Quote or Release During the Review *** Page 3 of 17

FOR FURTHER INFORMATION CONTACT: Jeff Kempter, Antimicrobials 1 Division, Office of Pesticide Programs, Environmental Protection Agency, 1200 2 Pennsylvania Ave., NW., Washingto n, DC 20460–0001; telephone number: 703-305- 3 5448; fax number: 703-308-6467; e-mail address: kempter.carlton@epa.gov

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SUPPLEMENTARY INFORMATION: 5

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I. General Information 7

A. Does this Action Apply to Me? 8

You may be potentially affected by this action if you apply fo r or own pesticide 9 registrations. Potentially affected entities may include, but are not limited to: 10

 Producers of pesticide products (NAICS 32532 11

 Producers of antimicrobial pesticides (NAICS 32561) 12

 Veterinary testing laboratories (NAICS 541940) 13

 Medical pathology laboratories (NAICS 621511) 14

 Taxidermists, independent (NAICS 711510) 15

 Surgeons (NAICS 621111) 16

 Dental surgeons (NAICS 621210) 17

 Mortician Services (NAICS 812210) 18

 Manufacturers of medical tis sue devices of human and animal origin (NAICS 19 code undetermined) 20

 Manufacturers of other human cellula r and tissue products (NAICS code 21 undetermined) 22

 Organ banks, body (NAICS 621991) 23

 Plasma, blood, merchant wholesalers (NAICS 424210) 24

This listing is not intended to be exha ustive, but rather provides a guide for 25 readers regarding entities likely to be affected by this action. Other types of entities not 26
listed in this unit could also be affected. The North American I ndustrial Classification 27 System (NAICS) codes have been provided to assist you and others in determining 28 whether this action might apply to certain en tities. If you have a ny questions regarding 29 the applicability of this ac tion to a particular entity, consult the person listed under FOR 30
FURTHER INFORMATION CONTACT

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B. What Should I Consider as I Prepare My Comments for EPA? 1

1. Submitting CBI . Do not submit this information to EPA through 2 regulations.gov or e-mail. Clearly mark the pa rt or all of the information that you claim 3
to be CBI. For CBI information in a disk or CD-ROM that you mail to EPA, mark the 4
outside of the disk or CD-ROM as CBI and then identify electronically within the disk or 5 CD-ROM the specific information that is clai med as CBI. In addition to one complete 6
version of the comment that includes inform ation claimed as CBI, a copy of the comment 7
that does not contain the information claimed as CBI must be submitted for inclusion in 8 the public docket. Information so marked will not be disclosed except in accordance with 9 procedures set forth in 40 CFR Part 2. 10

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2. Tips for preparing your comments . When submitting comments, remember to: 12

i. Identify the document by docket ID nu mber and other identifying information 13 (subject heading, Federal Register date and page number). 14

ii. Follow directions. The Agency may ask you to respond to specific questions or 15 organize comments by referencing a Code of Federal Regulations (C FR) part or section 16
number. 17

iii. Explain why you agree or disagree; suggest alternatives and substitute 18 language for your requested changes. 19

iv. Describe any assumptions and provid e any technical information and/or data 20 that you used. 21

v. If you estimate potential costs or bu rdens, explain how you arrived at your 22 estimate in sufficient detail to allow for it to be reproduced. 23

vi. Provide specific examples to illustra te your concerns and suggest alternatives. 24

vii. Explain your views as clearly as possible, avoidi ng the use of profanity or 25 personal threats. 26

viii. Make sure to submit your comments by the comment period deadline 27
identified. 28

II. Background 29

A. What Action is the Agency Taking? 30

The Environmental Protection Agency (EPA or the Agency) has decided that 31 under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) a prion is 32 considered to be a pest, and proposes to decl are a prion to be a pe st and to explicitly 33 include them in the lists of pests in 40 CF R Part 152.5. These actions would affirm the 34 Agency’s authority to regulat e products distributed or sold for the purpose of reducing 35 the infectivity of prions on inanimate surfaces (i.e., prion -related products). Prion -related 36*** EO 12866 Review Draft – Delib erative – Do Not Cite, Quote or Release During the Review *** Page 5 of 17

products are currently regulated under FI FRA and subject to all requirements and 1 provisions of the Act based on EPA’s Sept ember 10, 2003 decision that prions share 2 enough characteristics of an “other micro-orga nism” or “form of life” (as those terms are 3 used in FIFRA) to fall within the scope of FIFRA section 2(t) and 40 CFR 152.5(d). 4 This proposal ensures that the regulatory de finition reflects the Ag ency’s authority to 5 regulate products distributed or sold for the purpose of reduc ing the infectivity of prions 6 on inanimate surfaces (i.e., prion -related products). The primary impact of declaring that 7 a prion is a pest and including “p rion” in the regulatory defini tion of “pest” is to provide 8 regulatory clarity that prion -related products must be registered or exempted under 9 FIFRA sections 3 or 18, respectively, before su ch products may be distributed or sold in 10
the United States. 11

12 Note that not all prions and prion-rela ted products are affected by the proposed 13 rule. Firstly, EPA’s regulations at 40 CF R 152.5(d) exclude pests “...in or on living man 14 or other living animals and those on or in processed food or processed animal feed, 15 beverages, drugs...and cosmetics.” Therefor e, the proposed rule would not apply to 16 those uses of prion-related products. Sec ondly, the definition of “pesticide” in FIFRA 17 Section 2(u) excludes new animal drugs and liquid chemical sterilants intended for use on 18
a critical or semi-critical device. Ac cordingly, products which fall into those categories 19 would not be covered by the proposed rule. 20

21 B. What is the Agency's Aut hority for Taking this Action? 22

This action is issued under the authority of sections 2 through 34 of FIFRA (7 23 U.S.C. 136-136y). 24

III. Prion As Pest under FIFRA 25

A. What is a Prion? 26

Prions (“ pr oteinaceous in fectious particles”) may o ccur in the central nervous 27 system tissues of animals as an abnormal (“mi sfolded”), infectious form of prion protein. 28 Prion protein in its normal form, or conformation, can be designated PrP c (“cellular” 29 isoform) while abnormal conformations of pr ion proteins are generally called prions. 30 Different types of prions are commonly designated by the type of diseases they produce, 31
such as PrP Sc (prions associated with scrapie) and PrP BSE (prions associated with bovine 32 spongiform encephalopathy—mad cow disease). 33

In the disease process, prions (such as PrP sc ) recruit normal prion proteins (PrP c ) 34 and convert them into pri ons (e.g., another copy of PrP Sc ). This recruitment and 35 conversion process results in the progressive accumulation of disease-producing prions. 36 When this process takes place in the brain, it causes disease that slowly progresses from 37 neuronal dysfunction and degenera tion to death. These neurodegenerative prion diseases 38 are known collectively as transmissible s pongiform encephalopathies (TSEs). TSEs 39 include scrapie disease in sheep, bovine spongiform encepha lopathy (BSE) in cattle, 40 chronic wasting disease (CWD) in deer a nd elk, kuru and variant Creutzfeld-Jakob 41 Disease (vCJD) in humans, and similar diseas es in other animals. The EPA and other 42*** EO 12866 Review Draft – Delib erative – Do Not Cite, Quote or Release During the Review *** Page 6 of 17

agencies are concerned that animal-related prions from animal species may infect may 1 spread to other animals (e.g., scrapie to sheep, CWD to cervids) or to humans (e.g., BSE 2 from cattle converting to vCJD in humans), or ), and that human-related prions of human 3 origin may spread. may be passed to other humans (e.g., kuru or CJD). These diseases are 4 always fatal in humans and animals alike, and there are no known treatments or cures. 5

B. Legal/Regulatory Background 6

Under section 25(c)(1) of FIFRA, the Ad ministrator, after notice and opportunity 7 for hearing, is authorized “to de clare a pest any form of plant or animal life (other than 8 man and other than bacteria, virus, and ot her micro-organisms on or in living man or 9 other living animals) which is injurious to he alth or the environment.” Therefore, the 10 Agency has the authority to decide whether or not a prion should be considered to be a 11 pest under FIFRA and whether to issue a regulation implementi ng that decision. 12

13 On September 10, 2003, the EPA decided that a prion should be considered to be 14 a “pest” under FIFRA and that products in tended to inactivate prions (i.e., “prion -related 15 products”) should be regulated under FIFRA (Ref . 1). This decision was made partly in 16 connection with the widespread occurrence of chronic wasting disease (CWD) among 17 deer and elk in a number of states, particul arly in the Rocky M ountain region. Although 18 CWD had been endemic to that region for a long time, concerns were growing inside and 19 outside of EPA as to how to prevent or minimize the movement of what is believed to be 20 the causative agent for CWD—prions —through the environment. 21

22 At the same time, EPA was receiving inqui ries from states about obtaining FIFRA 23 Section 18 exemptions to allow use of a disi nfectant against prions on inanimate surfaces 24 in government and commercial laboratories. EPA was also aware that the Centers for 25 Disease Control and Prevention (CDC) and the World Health Organization (WHO) were 26

reco mmending recommended the use of certain chemicals sodium hydroxide or sodium 27 hypochlorite for treating surfaces and items potentially contaminated with prions even 28 though those chemicals were not registered by EPA for that sp ecific purpose. Subsequent 29 to the September 2003 decision, the EPA has granted a total of 19 quarantine exemptions 30 under FIFRA Section 18 to numerous states (California, Colorado, Maine, Minnesota, 31 Montana, North Dakota, South Dakota, Utah, Wyoming and Maine) and USDA for the 32 use of a commercial aqueous acid phenolic product, Environ LpH, for treatment on hard, 33 nonporous surfaces in government and commercial laboratories contaminated with CWD 34 and other kinds of prions. 35

36 Other Federal agencies are responsible for implementing controls to prevent the 37 spread of prion diseases to animals and humans . For example, to eliminate scrapie within 38 the United States, USDA's APHIS administer s the national scrapie eradication program 39 (9 CFR parts 54 and 79). APHIS also intends to establish a herd certification program to 40 prevent and control CWD from farmed or captive cervids in the United States (9 CFR 41 parts 55 and 81). In addition, APHIS regulates the importation of animals and animal 42 products into the United States to guard against the introduction of various animal 43 diseases, including BSE (9 CFR parts 92, 93, 94 and 95). To prevent the spread of BSE 44 through animal feed, the FDA prohibits th e use of most mammalian protein in the 45*** EO 12866 Review Draft – Delib erative – Do Not Cite, Quote or Release During the Review *** Page 7 of 17

manufacture of animal feed used for rumina nts and prohibits high risk cattle materials 1 from all animal feed (21 CFR part 589). To prevent potential human exposure to the 2 BSE agent, USDA's FSIS prohibits for use as human food cattle ma terials that could 3 potentially contain the BSE agent (9 CFR 310.22). FDA has also issued an interim final 4 rule (69 FR 42256, July 14, 2004) prohibiting the use of certain cattle materials in human 5 food and cosmetics to address the poten tial risk of BSE (21 CFR 189.5 and 700.27). 6

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C. EPA’s Interpretation of FIFRA 8

1. Applicable FIFRA Provisions 9
10 FIFRA Section 25(c)(1) author izes the Administrator “to declare a pest any form 11 of plant or animal life (other than man and other than bacteria, virus, and other micro12 organisms on or in living man or other living animals) which is injurious to health or the 13 environment.” FIFRA Section 2(t) defines a pest, in part, as “... any other form of 14 terrestrial or aquatic plant or animal life or virus, bacteria or other micro15 organism...which the Administrator declares to be a pest under sec tion 25(c)(1).” These 16 FIFRA sections provide EPA the authority to declare something an entity to be a “pest” if 17 it meets these statutory provisions. 18
19

2. EPA’s Interpretation of FIFRA 20

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EPA’s decision to declare a prion to be a pest under FIFRA rests on its statutory 22 interpretation of FIFRA Secti ons 25(c)(1) and 2(t). EPA beli eves that Congress intended 23 that the phrases “any other form of plant or animal life” and “other micro-organism” be 24 broadly interpreted to include biological entities that ar e injurious to humans or the 25 environment. The following points provide EPA’s rationale for this interpretation. 26

27

 In FIFRA, Congress has over the years us ed the term “other micro-organism” 28 more broadly than most microbiologists cu rrently would define the term because, 29 as used in FIFRA, the term “micro-organism” includes viruses, which many 30 microbiologists do not consider to be mi croorganisms. Therefore, the term 31 “micro-organism,” as currently defined by many microbiologists, is narrower than 32 the potential scope of the term “o ther micro-organism” in FIFRA. 33

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 As used in FIFRA, the term “other mi cro-organism” includes entities other than 35 viruses and bacteria, but it is unclear which entities. It is reasonable to assume 36 that it includes those entities that most microbiologists currently recognize as 37 microorganisms (i.e., microfungi, yeasts, a nd protists). Because the statutory 38 language explicitly includes viruses among micro-organisms in the definition of 39 “pest,” the term "other micro-organism" in its statutory context reasonably may be 40 interpreted to include some other en tities that many microbiologists may not 41 categorize as microorganisms. 42

43

 Today, microbiologists do not generally classify viruses as microorganisms 44 because they are not alive (i.e., they cannot reproduce sexually or asexually

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grow or perform self-maintenance). Ther efore, the term “other micro-organism” 1 as used in FIFRA appears broad enough to include some entities that are not alive. 2

3

 Congress’ rationale for including viruses w ithin the FIFRA definition of “pest” is 4 not known as there is no available legislativ e history on this issue. However, it is 5 reasonable to infer that Congress included viruses within the FIFRA definition of 6 “pest” and within the scope of the meaning of “micro-organism” because viruses 7 share important characteristics of other pest s. The characteristics of a virus that 8 make it resemble a micro-organism in th e context of “pest” are pathogenicity, 9 infectivity, transmissibility, the ability to increase in number and the ability to 10 evolve. EPA believes that Congress intend ed the terms “pest” and “other micro11 organism” as used in FIFRA to be broadly inclusive. 12

13

 One entity that shares the characteristics of pathogenicity, infectivity, 14 transmissibility, the ability to increase in number and the ability to evolve (but 15 which, like viruses, is not alive) is the prion , which . A prion is an infectious 16
conformation agent occurring in the tissues of animals that is widely, though not 17 universally, believed to be composed of an abnormal ( misfolded prion ) protein 18
that causes TSE d iseases in humans and animals

. without nucleic acid. Prions are 19 also unquestionably injurious to the health of humans and other animals. They 20
cause TSE diseases that attack the ner vous system, inflict irreversible damage, 21 and are always fatal to infected animals and humans. These infectious particles, 22

once Once introduced into an animal or human

, host, prions can induce neuronal 23
cells to change into prions that in turn attack other neuronal cells, primarily in the 24 central nervous system. Finally, formation of new prions in the animal or human 25
host. Prions are considered among the most diffi cult of all biological entities to 26 mitigate and few methods are available for effectively doing so. Moreover, 27
current test methods cannot demonstrate co mplete destruction or inactivation of 28 prions. For these reasons, EPA believes th at the public needs assurance of the 29 safety and efficacy of products intended to reduce the infectivity of prions. 30

31

 Congress expressly included “prion” within another statute’s definition of “pest” 32
in the Animal Health Protection Act of 2002. 33

34 For these reasons, EPA concluded that a prion is appropriately included in the 35 phrase “other micro-organism.” Because prions are also severely injurious to human and 36 animal health, EPA has also concluded that a prion s is appropriately included in the 37 FIFRA definition of “pest .” 38
39

D. EPA’s Prion Science Evaluation and Efficacy Test Guidance Documents 40

To assure that this rulemaking is based on the best available scientific 41 information, EPA reviewed and summarized th e most relevant scie ntific studies and 42 publications related to the issue of whether a prion is a pest in a “white paper” (Ref. 2). 43 EPA presented the draft white paper to the FIFRA Scientific Advisory Panel (SAP) for 44 peer review and comment on March 31 and April 1, 2009. The SAP provided comments 45*** EO 12866 Review Draft – Delib erative – Do Not Cite, Quote or Release During the Review *** Page 9 of 17

to EPA on the draft white paper on June 29, 2009 (Ref. 3). EPA subsequently responded 1 to the SAP’s comments (Ref. 4) and made revi sions to the white paper in response to the 2 SAP comments (Ref. 5). All of these refere nced documents are available in the docket 3 for this declaration and proposed rule. 4

IV. FIFRA Review Requirements 5

6 [ Note to reviewers: this section will be filled in once FIFRA review is completed

. ] 7
8 In accordance with FIFRA section 25(a), EPA has submitted a draft of the 9 proposed rule to the FIFRA SAP, the Secret ary of Agriculture (USDA), and appropriate 10 Congressional Committees. 11

12 The FIFRA SAP waived its review of this pro posal on [ insert date ], because the 13 significant scientific issues involved have already been reviewed by the SAP and 14
ad ditional review is n’t necessary. 15

16 Comments on the draft proposal receiv ed from USDA have been addressed [ or 17 revise say they did not co mment

. Or say

... USDA participated fully in the interagency 18 review process under Executive Order 12866, during which EPA and USDA discussed 19 [ enter major topic areas that were raised and resolved ]

. 20

21 In addition, pursuant to FIFRA section 21(b), EPA submitted a draft of the proposed rule 22 to the Secretary of Health and Human Services (HHS). [ Did they comment or not? If 23 we got comments, include ]. Comments on the draft proposal received from HHS have 24 been addressed [ or revise say they did not comment . Or say...HHS participated fully in 25 the interagency review process under Ex ecutive Order 12866, during which EPA and 26

HHS discussed [ enter major topic areas that were raised and resolved ]. 27

28 The FIFRA SAP waived its review of this proposal on June 1, 2010, because the 29 significant scientific issues involved have already been reviewed by the SAP and 30
additional review isn’t necessa ry. A copy of this waiver is available in the docket. 31

32 As required by FIFRA section 25(a), th e written comments on the draft proposal 33 received from USDA and HHS, along with EP A responses, are available in the docket. 34 EPA addressed these comments as part of the interagency review process under 35 Executive Order 12866, and changes made to the proposed rule in response to all 36 comments received during that interagency review are documented in the docket as 37 required by Executive Order 12866. 38
39 V. Statutory and Executive Order Reviews 40

41 A. Regulatory Review 42
43 Pursuant to Executive Order 12866, entitled Regulatory Planning and Review (58 44 FR 51735, October 4, 1993), the Office of Management and Budget (OMB) has 45 determined that this proposed rule is a "significant regulatory action" because this action 46*** EO 12866 Review Draft – Delib erative – Do Not Cite, Quote or Release During the Review *** Page 10 of 17

might raise novel legal or policy issues aris ing out of legal mandates, the President’s 1 priorities, or the principles set fort h in the Executive Order. Accordingly , as a result of 2
this OMB determination , EPA submitted this proposed rulemaking to OMB for review 3 under Executive Order 12866. Any changes made in response to OMB comments have 4
been documented in the public docket for this rulemaking as required by sec. 6(a)(3)(E) 5
of the Executive Order. 6

7 EPA has prepared an economic analysis of the potential costs associated with this 8 proposed action, entitled “Economic Analys is of the Notice of Proposed Rulemaking 9 Concerning the Status of Prion as a Pest under the Federal Insecticide, Fungicide, and 10 Rodenticide Act (FIFRA)” (Ref . 8). A copy of this document is available in the docket 11 for this rulemaking, and is briefly summarized here. 12

13

The Economic Analysis (EA) presents the Agency’s assessment of the potential 14 costs and benefits expected to result from th e proposed rule. In terms of benefits, the 15 proposed rule will ensure that EPA can pr otect human health and the environment by 16 subjecting prion -related products to regulation under FI FRA, including all data and 17 labeling requirements. In terms of costs, using pre-2003 costs as the baseline, the 18 incremental costs of the proposed rule pe r registration action ra nge from $424 thousand 19 to $4.72 million. 20

The EA presents the costs of various t ypes of registrations under the proposed 21 rule and presents expected incremental cost s for three product registration types. The 22 three types of registration actions which are possible under the pr oposed rule are the 23 registration of (1) a new activ e ingredient, (2) a new use product, or (3) a new use 24 amendment registration. 25

The EA estimates that three firms may seek registrations for major new use 26 products in the first year. If all uses are high exposure (e.g., indirect food uses), the 27 maximum potential total cost to industry in the first ye ar would be approximately $7.05 28 million, and costs per firm would be approxi mately $2.35 million. Given the uncertainty 29
that characterizes th e market for prion -related products at this time, the Agency did not 30 speculate further on the expected number of registrations in subsequent years. However, 31 registrations that occur af ter the initial major new use product registrations would 32 probably be major new use amendments. Data requirements would entail only product33 specific efficacy data for major new use amendments at a cost of approximately $431,000 34 per registration action. Approximately 80% of the firms in the pesticide manufacturing 35 industry are small firms with revenues of $22 million, on average. A cost of $7.05 36 million suggests that the incremental cost per firm of $2.35 million dollars would equal 37 nearly 11% of annual revenues. However, af ter the initial three registrations, a major 38 new use amendment at a cost of $431,000 woul d represent fewer than 2% of average 39
annual revenues. 40

The EA identifies three categories of persons who could be affected by the 41 proposed rule—pesticide regi strants, users of prion -related products and researchers. The 42 registration related requirements under FIFRA, however, are imposed on the entity that 43*** EO 12866 Review Draft – Delib erative – Do Not Cite, Quote or Release During the Review *** Page 11 of 17

registers the prion -related product. Users of prion -related products and researchers are 1 affected indirectly. The EA summarizes potential qualitati ve impacts of regulating prion

2
related products that were expressed by product users to EPA during its outreach efforts 3
to these users. 4

The EA evaluates the impacts of the data required to support the registration of a 5 prion -related product, specifically the need for a product performance test that will 6 measure the ability of an individual product to reduce the infectivity of prions. The 7 Agency has developed draft test guidelines fo r prions which will ensure that the Agency 8 receives the data needed to make objective and reliable determinations as to whether a 9 prion -related product meets the Agency’s efficacy data requirements for registration. 10 Providing clear guidance on EPA’s effi cacy data requirements for prion -related products 11 will benefit registrants by enabling them to submit relevant, correct and complete data 12 submissions in support of applicatio ns for registration to the Agency. 13

One unintended consequence of using products approved for use under FIFRA 14 Section 18 exemptions is that at least one stat e, California, requires that such products be 15 applied only by certified app licators. EPA further understa nds, however, that California 16 has no such requirement for pesticide products that are registered under FIFRA Section 3 17 or 24(c) that are not classified for restricted use. Hence, laboratories in CA that use 18 prion-related products register ed under Section 3 or 24(c) would not be subject to a 19 certified applicator requirement. The initial cost of obtaining the ce rtified applicator’s 20 license in California is $140, and the renewal fee is $60 every two years (see 21 http://www.cdpr.ca.gov/docs/license/qac.htm) . In addition, 20 hours of continuing 22 education is required to obtain renewal. If a similar requirement is imposed by other 23 states, the cost to laboratorie s for obtaining applicator licen ses would probably be about 24
the same. No such cost is associated with products registered unde r Section 3 or 24(c). 25

B. Paperwork Activities 26

27 The information collection requirements, i.e., the paperwork collection activities, 28 contained in this proposal are already a pproved by OMB under the Paperwork Reduction 29 Act (PRA), 44 U.S.C. 3501 et seq . Specifically, the activities contained in this proposed 30 rule are already addressed in the followi ng information collection requests (ICRs): 31

32
1. The activities associated with the es tablishment of a tolerance are currently 33 approved under OMB Control No. 2070-0024 (EPA ICR No. 0597); 34

35
2. The activities associated with the a pplication for a new or amended registration 36 of a pesticide are current ly approved under OMB Control No. 2070-0060 (EPA ICR No. 37 0277); and 38
39
3. The activities associated with the generation of data in response to a Data-Call40 In issued subsequent to regist ration (e.g., as part of the review of an existing registration), 41 are currently approved under OMB C ontrol No. 2070-0174 (EPA ICR No. 2288). 42

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The existing ICRs cover the paperwor k activities containe d in this proposal 1 because the activities already occur as part of existing program activities. These program 2 activities are an integral part of the Ag ency pesticide program and the corresponding 3 ICRs are regularly renewed. Although this pr oposal involves alrea dy approved activities, 4 the estimated frequency of those activities may increase as a result of this proposal. The 5 total estimated average annua l public reporting burden currently approved by OMB for 6 these various activities range s from approximately 8 hours to 3,000 hours per respondent, 7 depending on the activity and other factors su rrounding the particular pesticide product. 8 According to EPA’s Economic Analysis for this proposed rule (Ref. 8), using the 9 estimate of three major new use product registrations in the first year, the additional 10 registration of three antimicrobial products ma king prion related clai ms will result in an 11 increase in new registration applications fo r the Agency from 140 to 143 and an increase 12 in tolerance petitions of from 64 to 67. The increase in paperwork burden for the 13 registrant will be nearly $38,000 (600 hours fo r three registrations) for registration 14
activities and a littl e more than $423,000 (5,200 hours for three registrations) for 15 paperwork for toleranc e petitions. (Ref. 8) 16

17 An agency may not conduct or sponsor, and a person is not required to respond to 18 an information collection request unless it displays a currently valid OMB control 19 number, or is otherwise required to submit the specific information by a statute. The 20 OMB control numbers for EPA’s regulations, afte r appearing in the preamble of the final 21 rule, are listed in 40 CFR part 9 and 48 CFR chapter 15, and included on the related 22 collection instrument ( e.g., form or survey). 23

24 Under the PRA, "burden" means the total time, effort, or financial resources 25 expended by persons to generate, maintain, reta in, or disclose or pr ovide information to 26 or for a Federal agency. This includes the time needed to review instructions; develop, 27 acquire, install, and utilize technology and systems for the purposes of collecting, 28 validating, and verifying information, pro cessing and maintaining information, and 29 disclosing and providing information; adjust the existing ways to comply with any 30 previously applicable instruc tions and requirements; train pe rsonnel to be able to respond 31 to a collection of information; search data s ources; complete and re view the collection of 32 information; and transmit or otherw ise disclose the information. 33

34 Comments are requested on the Agency’s need for this inform ation, the accuracy 35 of the burden estimates, and any suggeste d methods for minimizing respondent burden, 36 including through the use of au tomated collection techniques. Send comments to EPA as 37 part of your overall comments on this pr oposed action in the manner specified under 38
ADDRESSES . In the final rule, the Agency will address any comments received 39 regarding the information collection requirements cont ained in this proposal. 40

C. Small Entity Impacts 41

42 Pursuant to section 605(b) of the Regul atory Flexibility Act (RFA), 5 U.S.C. 601 43

et seq ., after considering the potential economic impacts of this proposed rule on small 44 entities, I hereby certify that this proposed rule would not have a significant adverse 45*** EO 12866 Review Draft – Delib erative – Do Not Cite, Quote or Release During the Review *** Page 13 of 17

economic impact on a substantial number of sm all entities. This de termination is based 1 on the Agency’s economic analysis (Ref. 8), and is briefly summarized here. 2

3 Under the RFA, small entities include sm all businesses, small organizations, and 4 small governmental jurisdictions. For purposes of assessing the impacts of today's rule 5 on small entities, small entity is defined as: (1) a small business as defined by the Small 6 Business Administration’s (SBA) regulations at 13 CFR 121.201 (in th is case based on 7 maximum number of employees or sales for sm all businesses in each industry sector, as 8 defined by a 6-digit NAICS code); (2) a small governmental jurisdiction that is a 9 government of a city, county, town, school distri ct or special district with a population of 10 less than 50,000; and (3) a small organization that is any not-fo r-profit enterprise which is 11 independently owned and operated and is not do minant in its field. Since the regulated 12 community does not include small government al jurisdictions or small not-for-profit 13 organizations, the analysis focuses on small businesses. 14

15 According to the Agency’s economic an alysis (Ref. 8), only three firms are 16 expected to apply for registrations of prion -related products. One of these firms is known 17 to be a large firm. Given that approximat ely 79% of the firms in the antimicrobial 18 industry are small firms, it is possible that any or all of the remaining two other firms 19 could qualify as a small enti ty under the SBA definition. 20

21 The incremental costs of the proposed ru le could represent from 2-11% of the 22 average annual revenues of a small firm. In general, the Agency does not believe that 23 prion -related products are an important market segment for sodium hydroxide or sodium 24 hypochlorite producing firms and does not anticipate a large number of product 25 registrations beyond the first year the final rule would take ef fect. If small entities apply 26 to register products for prion control, they would likely pursue a registration where they 27 could likely cite a substantial amount of data and not incur 100% of the initial costs of 28 testing. (Ref. 8). 29

30
EPA continues to be interested in the potential impacts of this proposed rule on 31 small entities and welcomes comments on issues related to such impacts. 32

33
D. Unfunded Mandates 34
35 This action does not contain any Federa l mandates for State, local, or tribal 36 governments or the private sector under th e provisions of Title II of the Unfunded 37 Mandates Reform Act (UMRA), 2 U.S.C. 1531 -1538. EPA has determined that this 38 regulatory action will not result in annual expe nditures of $100 million or more for State, 39 local, and tribal governments, in the aggregate, or for the private sect or. As described in 40 Unit IV.A., the incremental co sts for the proposed rule are estimated from $424 thousand 41 to $4.72 million. Since State, local, and tr ibal governments are rarely pesticide 42 applicants, the proposed rule is not expected to significantly or uniquely affect small 43 governments. As such, EPA has determined that this action does not impose any 44 enforceable duty, contain any unfunded mandate, or otherwise have any affect on small 45*** EO 12866 Review Draft – Delib erative – Do Not Cite, Quote or Release During the Review *** Page 14 of 17

governments. Accordingly, this action is not subject to the requireme nts of sections 202, 1
203 or 205 of UMRA. 2

3 E. Federalism Implications 4
5 Pursuant to Executive Order 13132, entitled Federalism (64 FR 43255, August 6 10, 1999), EPA has determined that this proposed rule does not have “federalism 7 implications” because it will not have substa ntial direct effects on the states, on the 8 relationship between the nati onal government and the states, or on the distribution of 9 power and responsibilities among the various le vels of government, as specified in the 10 Order. As indicated previously, instances wher e a state is a registrant are extremely rare. 11 Therefore, this proposed rule may seldom affect a state government. Thus, Executive 12 Order 13132 does not apply to this proposed rule. 13

14 In the spirit of the Order, and c onsistent with EPA policy to promote 15 communications between the Agency and Stat e and local governments, EPA specifically 16 solicits comment on this proposed rule from State and local officials. 17

18 F. Tribal Implications 19
20 As required by Executive Order 13175, entitled Consultation and Coordination 21
with Indian Tribal Governments (65 FR 67249, November 6, 2000), EPA has determined 22 that this proposed rule does not have “tri bal implications” because it will not have 23
substantial direct effects on tribal governments, on the rela tionship between the Federal 24 government and the Indian tribes, or on the distribution of power and responsibilities 25 between the Federal government and Indian tr ibes, as specified in the Order. As 26 indicated previously, at pres ent, no tribal governments hold, or have applied for, a 27 pesticide registration. Thus, Executive Order 13175 does not apply to this proposed rule. 28
29 In the spirit of the Order, and c onsistent with EPA policy to promote 30 communications between the Agency and Stat e and local governments, EPA specifically 31 solicits comment on this proposed rule from tribal officials. 32

33
G. Children’s Health 34
35 EPA interprets Executive Order 13045, entitled Protection of Children from 36
Environmental Health Risks and Safety Risks (62 FR 19885, April 23, 1997), as applying 37 only to those regulatory actions th at concern health or safety ri sks, such that the analysis 38 required under section 5-501 of Executive Orde r 13045 has the potential to influence the 39 regulation. This action is not subject to Executive Order 13045 because it does not 40
establish an environmental standard intended to mitigate health or safety risks, and it is 41 not designated as an “econo mically significant” regulatory action as defined by Executive 42 Order 12866 (see Unit V.A.). To the contrar y, this action will provide added protection 43 for children from pesticide risk. 44

45 H. Energy Effects 46*** EO 12866 Review Draft – Delib erative – Do Not Cite, Quote or Release During the Review *** Page 15 of 17

1 This action is not a “significant energy action” as defined in Executive Order 2 13211, entitled Actions Concerning Regulations that Significantly Affect Energy Supply, 3 Distribution, or Use (66 FR 28355, May 22, 2001), because it is not likely to have an 4 effect on the supply, distribut ion, or use of energy as described in the Order. 5

6
I. Technical Standards 7
8 Section 12(d) of the Na tional Technology Transfer and Advancement Act of 1995 9 (NTTAA), 15 U.S.C. 272 note, directs EPA to use voluntary consensus standards in its 10 regulatory activities unless to do so would be inconsistent with applicable law or 11 impractical. Voluntary consensus st andards are technical standards ( e.g ., materials 12 specifications, test methods, sampling procedures, etc .) that are devel oped or adopted by 13 voluntary consensus standards bodies. N TTAA directs EPA to provide Congress, 14 through OMB, explanations when the Agency de cides not to use avai lable and applicable 15 voluntary consensus standards. 16

17 This action does not propose to require a ny technical standards that would require 18 Agency consideration of voluntary consensus st andards. This action proposes the types 19 of data to be required to s upport the registration of antimicr obial pesticide products with 20 prion-related claims but does not propose to require specific methods or standards to 21 generate those data. 22

23 The Agency invites comment on its conclusion regarding the applicability of 24 voluntary consensus standa rds to this rulemaking. 25

26

J. Executive Order 12898 Environmental Justice 27
28 This proposed rule does not have an adverse impact on the environmental and 29 health conditions in low-income and minority communities. Therefore, under Executive 30 Order 12898, entitled Federal Actions to Address Envi ronmental Justice in Minority 31 Populations and Low- Income Populations (59 FR 7629, February 16, 1994), the Agency 32
does not need to consider envir onmental justice-related issues. 33

34
VI. References 35
36
As indicated under ADDRESSES , a docket has been established for this 37 rulemaking under docket ID number EPA-HQ-OPP-2010-____. The following is a 38 listing of the documents that are specifically referenced in this document. The docket 39
includes these documents and other informati on considered by EPA in developing this 40 proposed rule, including documents that are referenced within the documents that are 41 included in the docket, even if the referenced document is not physic ally located in the 42 docket. For assistance in locating these othe r documents, please consult the technical 43
contact listed under FOR FURTHER INFORMATION CONTACT

. 44

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1. U.S. Environmental Protection Agency. 2004. Considerations of Prions as a Pest 1
under FIFRA. Memorandum to The Record from Susan B. Hazen, Principal Deputy 2 Assistant Administrator, Office of Preventi on, Pesticides, and Toxic Substances. April 3 29, 2004. 4

5 2. U.S. Environmental Protection Agency. 2009. “Scientific Information Concerning the 6
Issue of Whether Prions Are a ‘Pest’ unde r the Federal Insecticide, Fungicide, and 7
Rodenticide Act.” Draft dated 2-23-09. 8

9 3. U.S. Environmental Protection Agency. 2009. Transmittal of Meeting Minutes of the 10 FIFRA Scientific Advisory Panel Meeting Held March 31 - April 1, 2009 on Scientific 11 Issues Associated with Designating a Prion as a ‘Pest’ under the Federal Insecticide, 12 Fungicide, and Rodenticide Act (FIFRA), and Related Efficacy Test Methods. 13 Memorandum from Myrta R. Christian, Designa ted Federal Official, FIFRA Scientific 14 Advisory Panel, Office of Science Coordi nation and Policy, to Debbie Edwards, Ph.D., 15 Director, Office of Pesticid e Programs. June 29, 2009. See 16 http://www.epa.gov/scipoly/sap/meeti ngs/2009/march/033109panelmembers.html 17

18 4. U.S. Environmental Protection Agency. 2010. EPA Responses to Comments by the 19 FIFRA Scientific Advisory Panel Concerni ng “Scientific Information Concerning the 20
Issue of Whether Prions Are a ’Pest’ unde r the Federal Insecticide, Fungicide, and 21 Rodenticide Act (FIFRA).” 2-17-10. 22

23 5. U.S. Environmental Protection Agency. 2010. Scientific Information Concerning the 24
Issue of Whether A Prion Is a “Pest” under the Federal Insecticide, Fungicide, and 25
Rodenticide Act. 2-17-10. 26

27 6. U.S. Environmental Protection Agency. 2009. Product Performance Test Guidelines 28
OPPTS 810:XXXX Products with Prion Re lated Claims. Draft dated 2-23-09. 29

30 7. U.S. Environmental Protection Agency. 2009. Product Performance Test Guidelines 31
OPPTS 810:XXXX Products with Prion Related Claims. Draft dated 12-8-09. 32

33 8. U.S. Environmental Protection Agency. 2010. Economic Analysis of the Notice of 34 Proposed Rulemaking Concerning that Status of a Prion as a Pest under the Federal 35 Insecticide, Fungicide, and Rode nticide Act (FIFRA). 2-17-10. 36

37 List of Subjects in 40 CFR Part 152.5 38
39 Environmental protection, antim icrobial pesticides, prion. 40

41 Dated: ________ 42

43

________________ 44

45

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_______________________ 1
Administrator 2

3 Therefore, it is proposed that 40 CFR chapter I be amended as follows: 4

5 1. The authority citation for part 152 would continue to read as follows: 6

Authority: 7 U.S.C. 136-136y; Subpart U is also issued under 31 U.S.C. 9701. 7

2. By amending 152.5(d) to add the term “prion” as follows: 8

§ 152.5 Pests

. 9

* * * * * 10 (a) * * * 11 (b) * * * 12 (c) * * * 13 (d) Any fungus, bacterium, virus, pr ion, or other microorganism, except for 14 those on or in living man or other living an imals and those on or in processed food or 15 processed animal feed, beverages, drugs (as defined in FFDCA sec. 201(g)(1)) and 16 cosmetics (as defined in FFDCA sec. 201(i)). 17

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